33 QA Technical Operations Jobs in Devens, MA
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Cynet Systems is Hiring a QA Technical Operations Near Devens, MA
Job Description:
Pay Range $62hr - $65hr
Responsibilities:
Pay Range $62hr - $65hr
Responsibilities:
- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
- Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations.
- Reviews and approves Quality, Quality Control, Validation and Automation related documents.
- Review and approve Standard Operating Procedures (SOPs).
- Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
- Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
- bility to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
- bility to self-manage and prioritize work across multiple competing deliverables, in a remote working environment.
- ble to interpret complicated data and make sound decisions, Independently.
- Sometimes I will interact with departments listed below.
- Quality Control.
- Manufacturing Operations.
- Manufacturing Engineering.
- Manufacturing Science and Technology (MS&T).
- Validation.
- Site Engineering.
- Digital Plant.
- Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
- dvanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product.
- quality. Preferred Active member of ASQ or ISPE.
- Prior experience of QC equipment Qualification and some project management experience.
- Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
- Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
- Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.
- Excellent Technical writing and oral communication skills are required.
- Background in problem solving.
- Knowledge of Data integrity principles.
- Proven attention to details.
- Comfortable working in an FDA regulated environment.
Job Summary
JOB TYPE
Full Time
SALARY
$121k-148k (estimate)
POST DATE
06/27/2024
EXPIRATION DATE
07/13/2024
WEBSITE
cynetsystems.com
HEADQUARTERS
ARCOLA, VA
SIZE
500 - 1,000
FOUNDED
2010
CEO
ASHWANI MAYUR
REVENUE
$50M - $200M
INDUSTRY
IT Outsourcing & Consulting
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